Angelini Pharma’s anti-seizure medicine approved 

Angelini Pharma has announced that cenobamate, an oral anti-seizure medicine (ASM), is now available for use within NHS Scotland as a treatment for eligible adults with uncontrolled focal epilepsy. The Scottish Medicines Consortium (SMC) has accepted cenobamate for restricted use in adults with drug-resistant epilepsy as a second-line adjunctive ASM, after failure of the first adjunctive ASM.¹ 

Context  

Across the UK, only 52% of people with epilepsy are seizure-free² and those with poorly controlled seizures are more likely to experience comorbidities, social stigmatisation and poor quality of life.³ 

The data 

The SMC decision follows the positive National Institute for Health and Clinical Excellence (NICE)  recommendation for cenobamate and is based on pivotal clinical trial data (study C017) published in The Lancet Neurology, demonstrating that drug-resistant focal-onset seizures were reduced by at least 50% in over half of patients when adding cenobamate (200 mg/day) to their daily treatment of 1–3 anti-seizure medications.⁴  

Furthermore, 11.2% of patients were seizure-free when taking 200 mg/day of cenobamate and this increased to 21.1% of patients taking the maximum daily dose 400 mg/day (during the 12-week maintenance phase).⁴ The most common adverse reactions reported included somnolence, dizziness, fatigue, vertigo, ataxia and headache.² 

Official comments 

Commenting on the announcement, John Paul Leach, Professor of Clinical Neurology at the University of Glasgow School of Medicine, said: “I welcome today’s decision on the use of cenobamate for some patients with resistant epilepsy. It marks an important step forward in epilepsy care in Scotland, giving physicians a new treatment option to help the one-third of patients who have epilepsies resistant to current anti-seizure medications. Clinical studies have shown that in some patients cenobamate can significantly reduce the frequency of focal-onset seizures offering them the potential for an improved quality of life.” 

“This is welcome news for people living with uncontrolled epilepsy in Scotland, whose lives are often debilitated by frequent seizures,” added Rona Johnson, Policy and Communications Manager at Epilepsy Scotland. “This decision means that eligible people with epilepsy in Scotland will now have access to a new treatment option that could significantly reduce the frequency of seizures for some, giving them the potential of improved quality of life.” 

Approval elsewhere 

Cenobamate has received marketing authorisation in Great Britain and authorised in the EU for the adjunctive treatment of focal-onset seizures with or without secondary generalisation in adult patients with epilepsy who have not been adequately controlled despite a history of treatment with at least two anti-epileptic medicinal products⁵. 

References 

1. Scottish Medicines Consortium. Cenobamate. Available at: https://www.scottishmedicines.org.uk/medicines-advice/cenobamate-ontozry-full-smc2408/ Accessed February 2022.
2. Epilepsy Action. Epilepsy facts and terminology. Available at: https://www.epilepsy.org.uk/press/facts Accessed February 2022.
3. National Institute for Health and Care Excellence. NICE Technical Appraisal Guidance [TA753]. Available at: https://www.nice.org.uk/guidance/ta753/chapter/3-Committee-discussion Accessed February 2022. 
4. Krauss L G et al. Lancet Neurol. 2020 Jan;19(1):38-48.
5. Cenobamate Summary of Product Characteristics (SmPC). Available at: https://www.medicines.org.uk/emc/product/13012/smpc#gref Accessed February 2022.